Photonic ATO ML 600 B User manual

CE MARK
Class I medical device in compliance
with the regulation MDR 2017/745/EU
INSTRUCTIONS FOR
OPERATION AND INSTALLATION
MINOR SURGICAL LIGHTS:
ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K
MOBILE STAND, CEILING MOUNT and
WALL MOUNT MODELS
As of: March 8, 2021
Version: V10.1
Doc: PT- 1

i
Dear Customer,
Congratulations on the purchase of your new ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K minor
surgical light from Photonic Optische Geräte GmbH & Co KG.
Our simple operating concept allows for intuitive handling using both the control panel on the housing
and the detachable handle. The light weight design of the light head and choice of quality and support
systems certified for the medical field with integrated power supply allow flexible use at your workplace.
The specially developed optical concept with innovative LED technology enables bright and homogene-
ous illumination of the work area while generating less heat than conventional halogen lights. This gives
you low-reflection lighting with high illuminance and a high color rendering index across the entire light
field.
We hope you enjoy your ATO ML 600 B | ATO ML 1000B | ATO ML 1000 K light !
Your team from
Photonic Optische Geräte GmbH & Co KG
1160 Vienna, Seeböckgasse 59
Austria
Tel.: [phone]
Fax: [phone]
[e-mail]
www.photonic.at

ii Instruction manual ML 600B | ML 1000B | ML 1000K
TABLE OF CONTENTS
1 Safety Instructions................................................................................................................. vi
2 Brief Description .................................................................................................................. vii
2.1 Versions ........................................................................................................................ viii
3 Operation................................................................................................................................1
3.1 Check Before Each Use....................................................................................................1
3.2 Operation of the Lamp Head ..........................................................................................1
3.2.1 Operation of the ATO ML 600 B | ML 1000 B Lamp Head......................................2
3.2.2 Quick Start via Sterilizable Handle...........................................................................2
3.2.3 Operation of the ATO ML 1000 K Lamp Head .........................................................3
3.3 Working Areas of the Support Systems..........................................................................4
3.3.1 Mobile Stand Model.................................................................................................4
3.3.2 Ceiling Mount Model ...............................................................................................6
3.3.3 Wall Mount Model...................................................................................................7
4 Safety Functions .....................................................................................................................8
4.1 Protection Against Overheating......................................................................................8
4.2 Undervoltage...................................................................................................................8
4.3 Power Outage..................................................................................................................8
4.4 Electrical Defect...............................................................................................................8
5 Equipotential Bonding Cunductor..........................................................................................9
6 Reprocessing of Sterile Accessories.....................................................................................10
6.1 Sterilizable Handle (also “Sterile Handle”) ...................................................................10
6.2 Desinfection...................................................................................................................10
6.3 Sterilization....................................................................................................................11
6.4 Verification/Durability...................................................................................................11
Signs of Material Wear ............................................................................................................11
7 Cleaning/Desinfection..........................................................................................................12
7.1 General Safety Instructions...........................................................................................12
7.2 Cleaning.........................................................................................................................12
7.3 Desinfection...................................................................................................................12
8 Maintenance.........................................................................................................................13
8.1 Support Systems............................................................................................................13
8.2 Lamp Head.....................................................................................................................13
9 Disposal.................................................................................................................................14
10 Mounting of the Lamp Head................................................................................................15
10.1 Lamp Head Assembly.................................................................................................15
10.2 Mobile Stand Assembly .............................................................................................17

iii
10.2.1 Mount Rollers.........................................................................................................17
10.2.2 Mount Stand Tube .................................................................................................18
10.2.3 Disassemble & Assemble Spring Arm / Safety Ring Correctly ..............................19
10.2.4 Adjust Spring Force ................................................................................................24
10.2.5 Replacing Fuses ......................................................................................................25
11 Mounting the Wall Fixture and Ceiling Fixture....................................................................27
11.1 Choice of Fasteners....................................................................................................28
11.2 Wall Mounting ...........................................................................................................28
11.3 Mounting the Ceiling Fixture.....................................................................................33
11.3.1 Mounting Ceiling Panel..........................................................................................33
11.3.2 Mounting Extension Arm with Spring Arm .....................................................................34
11.3.3 Replacing the Fuse of the Ceiling Mount...............................................................35
11.4 Adjust Spring Force....................................................................................................37
11.5 Drilling Template........................................................................................................38
12 Data.......................................................................................................................................39
12.1 Photometric Data for ATO ML 600 B | ATO ML 1000 K............................................39
12.2 Electrical and Other Technical Data..........................................................................42
12.3 Ambient Conditions...................................................................................................42
12.4 Electromagnetic Compatibility..................................................................................43
12.4.1 Immunity to High-Frequency Electromagnetic Fields in the Direct Vicinity of Wireless Com-
munication Devices ..................................................................................................................45
12.5 Measures in the Event of Malfunctions or Changes in Performance.......................46
12.6 Inspection Plan for the Lamp Head and Associated ATO ML 600 B | ATO ML 1000B
| ATO ML 1000 K Holding System ...........................................................................................46
13 ATO ML 600 B | ATO ML 1000 K Reference Numbers ........................................................48

iv Instruction manual ML 600B | ML 1000B | ML 1000K
SYMBOLS IN THE INSTRUCTIONS FOR OPERATION AND INSTALLATION
SYMBOL
MEANING
WARNING
Non-observance may result in serious or even fatal injury
CAUTION
Failure to do so may result in minor to moderate injury or damage to property
NOTE
Gives application tips and useful information
FOLLOW THE OPERATING INSTRUCTIONS
Read the operating instructions carefully before using the support system for the
first time. This will ensure that you benefit from all the advantages offered by the
support system and avoid potential injuries and damage to property
INFORMATION
for users, operators and third parties (technicians)
AMBIENT TEMPERATURE
Shows the permitted ambient temperatures from -25 °C to 70 °C for transport and
storage
OBSERVE MAXIMUM PAYLOAD
Warns of exceedance of the permitted maximum payload on the support arm sys-
tem, an adaptation as well as the use of a terminal device other than the ML 600B
/ ML 1000K light head.
AIR PRESSURE
Shows the permitted air pressure values from 500 hPa to 1060 hPa for transport
and storage
HUMIDITY
Shows the permitted humidity values from 10% to 75% for transport and storage
ELECTRIC SHOCK
Warns against electric shock, which may cause serious injury or even death
FALLING OF THE LIGHT FIXTURE
Warns of the sudden collapse of the support arm system due to the maximum
payload being exceeded
SYMBOL
MEANING

v
SPRINGING OPEN OF THE SPRING ARM
Warns of the sudden springing open of the spring arm when disassembling the
end device.
TIPPING HAZARD
The support arm system, especially the mobile stand version, is only designed to
support the weight of the light head. If additional weight is added, the unit may
tip over, potentially hitting people and causing serious injury. Do not climb or
lean on the stand. Do not attach any other loads to or on the device
MOVING THE UNIT
Note that before moving the stand unit (arrow 2), the spring arm must be set to the
lowest position (arrow 1).
• Make sure that the lockable rollers are unlocked.
• Watch for bumps, thresholds, landings at elevator entrances or other obstacles.
• Ensure that you move at an appropriate speed so that it is possible to stop and
take evasive action at any time. Watch out for inclined planes.
Please keep the operating instructions/assembly instructions in a safe place near the device!

vi Instruction manual ML 600B | ML 1000B | ML 1000K
1 SAFETY INSTRUCTIONS
Please observe the operating instructions when handling the light!
The light is a class I medical device according to EU 2017/745.
Surroundings:
• This device is not intended for operation in potentially explosive areas!
• Do not use in oxygen-enriched areas!
• Do not use near flammable anesthetic gases!
• Do not place near strong magnetic fields such as MRI systems!
• Do not cover the top of the lamp head! Risk of overheating!
• In operating rooms with displacement ventilation: Do not block the ventilation with the
light!
• In the operating room with displacement ventilation: Position the light at an angle to the
flow!
• Store the light in the packaging for at least 24 hours before mounting in the room to avoid
droplet formation due to condensation!
Support arm system
• Only use the supplied support arm system for lamp suspension!
• The entire system must be completely disconnected from the mains supply before mount-
ing!
• Please observe the enclosed operating instructions from ONDAL!
• The support arm system is intended exclusively for the suspension of the ML 600B or ML
1000K. Do not attach or stack other units!
Electronic and optical safety
• When using several lights, the total irradiance must be < 1000 W/m
2
!
• Only connect the unit to the mains supply with the protective ground conductor con-
nected!
• Only use the integrated or enclosed power supply unit on the support arm system!
• The light does not include a fail-safe power supply or an emergency battery!
• In the event of a power failure, the light will be switched off completely!
• Keep a backup unit ready in the operating rooms to ensure fail-safe operation!
• Short interruptions in lighting are possible in the event of external EMC interference!
• Only connect the device to a fused power supply (max. 20 A)!
• To switch off the lamp completely, the mains plug must be removed from the socket or the
live socket must be deactivated by a separate switch!
Maintenance and liability
• Electrical, installation or maintenance work must be carried out by qualified personnel!
• The manufacturer is not liable for damage caused by improper use!
• The manufacturer is responsible for the safety of the lamp only if repairs and modifications
are carried out by the manufacturer itself or by a company that guarantees compliance
with the safety regulations, using original spare parts!
Before each use,
make sure that the lamp is in perfect technical condition.

vii
2 BRIEF DESCRIPTION
TARGET GROUP
These operating instructions (including the operating instructions for the support systems) are intended for
health care professionals who use, clean, disinfect and sterilize the ATO ML 600 B | ATO ML 1000B | ATO
ML 1000 K minor surgical lights. The installation instructions for the holding systems are intended for qual-
ified and trained technical personnel.
KEY PERFORMANCE FEATURES
The lights are used to supply lighting for examination or surgical areas.
INTENDED USE
PHOTONIC's ML 600B, ML 1000B and ML 1000K minor surgical lights are designed for non-invasive, superfi-
cial illumination of the entire human body in the visible spectral range for the purpose of examinations,
outpatient and inpatient treatments, and surgical procedures by medical professionals. The illumination is
used only for optimum visibility of the examination or surgical area and has no diagnostic or therapeutic
effect. Illumination is external to the body and the equipment does not come into contact with patients.
The ML 600B, ML 1000B and ML 1000K minor surgical lights are intended for use in all rooms used for med-
ical purposes (group 0, 1, 2) –especially operating rooms.
INDICATION
The ML 600B, ML 1000B and ML 1000K minor surgical lights are used to illuminate examination or surgical
areas to support in diagnoses and treatments, especially during surgical operations. The light itself has no
diagnostic or therapeutic effect.
CONTRAINDICATION
The ML 600B, ML 1000B and ML 1000K minor surgical lights are not designed for use in dental work environ-
ments.
The products should only be used in operating rooms in conjunction with an uninterruptible power supply
and a fail-safe backup unit.
The products must not be used in the vicinity of strong magnetic fields (e.g. magnetic resonance tomographs).
Use of the equipment in oxygen-enriched atmospheres and in the vicinity of flammable anesthetic gases is
prohibited.
If several lights are operated together, make sure that the total irradiance does not exceed 1000 W/m² to
avoid excessive heat generation in the operating area.
RESIDUAL RISKS –RISK IN THE EVENT OF DAMAGE TO THE LIGHT FIXTURE
Protect the light fixture from impacts. Collision with other objects can lead to failure of the light and/or
damage to the housing and the support arm system, causing parts to fall.
The fixture does not include a fail-safe power supply. A power failure will cause the fixture to shut
down.
INCIDENTS AND REPORTS
The lighting systems must be reported to the competent authority in case of serious incidents. Even
the possibility of causal involvement of the medical device in a serious incident is subject to reporting.
According to the Medical Devices Regulation (MDR), the notification must be reported to the compe-
tent authority without delay.

viii Instruction manual ML 600B | ML 1000B | ML 1000K
2.1 VERSIONS
The ATO ML 600B, ATO ML 1000B and ATO ML 1000K minor surgical lights are offered in combination with the
corresponding support arm systems in the following versions:
Mobile stand: ATO ML 600B / ML 1000B / ML 1000K with ATO ACSwing mobile stand
Wall mount: ATO ML 600B / ML 1000B / ML 1000K with ATO ACSwing wall mount
Ceiling mount: ATO ML 600B / ML 1000B / ML 1000K with ATO ACSwing ceiling mount 200/400/600/800/1000

1
3 OPERATION
3.1 CHECK BEFORE EACH USE
• Check the system for visible deformation. If such are detected, contact service immediately.
• Ensure that the system has the required hygiene status for use.
• Before each start-up, the entire unit must be checked for proper functioning. The unit should be moved in
each degree of movement while checking the main function and the control system.
• If a lamp head is too difficult to move or no longer holds its position, the holding tensions can be adjusted
according to the operating instructions for supports and stands.
• Check handle for cracks.
Do not operate the fixture if there is any doubt about its electrical safety or static and dynamic stability.
3.2 OPERATION OF THE LAMP HEAD
The simple and ergonomic operating concept of the ATO ML 600 B │ ATO ML 1000B | ATO ML 1000 K enables
intuitive operation by the user. The lamp head is connected to the support system via a bracket. The lamp head
support allows the light to rotate approximately 270° in its holder. The 360° joint on the support system allows
rotation around the horizontal axis. The sterilizable handle allows both positioning of the lamp head and brightness
adjustment of the light during use. Turning the sterilizable handle counterclockwise increases the illumination, while
turning it clockwise reduces it. The blue "sterile handle" (the assembly consists of a sterilizable handle and clip) for
the ATO ML 600 B | ML 1000 B | ML 1000 K is not supplied sterile and must be disinfected and sterilized before first
use as described in Chapter 4. The brightness indicators above the handle pulsate in standby mode with the lowest
value indication LED.
The light automatically goes into standby mode as soon as mains power is connected. To completely switch off
the light, the following must be taken into account, depending on the type of installation:
Mobile stand: Pulling the mains plug switches the light off completely
Wall mount: Pulling the wall power supply switches the light off completely
Ceiling mount: Switching off the current-carrying socket by means of switch provided by customer

2
3.2.1 OPERATION OF THE ATO ML 600 B | ML 1000 B LAMP HEAD
The controls for switching on and off (position 3) and for brightness control (position 6) are integrated into the top
of the lamp head. The handle allows you to adjust the luminosity by turning the handle.
1
270° joint
2
360° joint/interface
Support system allows rotation around
the horizontal axis.
3
ON/OFF switch
4
Heat sink
5
Adjust brightness in 6 (ML 600B) or 10
(ML 1000B) steps:
(+) increase the illuminance level
(-) decrease the illuminance level
6
Lateral handle strip (for non-sterile op-
eration and positioning of the lamp
head).
7
Illuminance display (visualizes the cur-
rent setting of the illumination in 5
steps)
8
Sterilizable handle with quick start and
brightness control
Figure 1: Schematic representation of the ATO ML 600 B | ATO ML 1000 B lamp head.
3.2.2 QUICK START VIA STERILIZABLE HANDLE
For time-critical applications (e.g., trauma room), the light can be turned on with a slight twist of the sterilizable
handle. The direction of rotation is independent of this. The light starts at the lowest brightness (10 klx) and can
thus also be easily started and operated in a sterile manner. After the procedure, the light must be switched off
using the non-sterile ON/OFF button on the top of the housing.
Figure 2.1: Schematic representation of the ATO ML 600 B | ATO ML 1000 B lamp head.

3
3.2.3 OPERATION OF THE ATO ML 1000 K LAMP HEAD
The controls for switching on and off (button A), color temperature selection (button B) and for brightness control
(buttons C and D) are integrated into the top of the lamp head. The handle allows you to adjust the luminosity by
turning the handle.
1
270° joint
2
360° joint/interface support system
3
Heat sink
4
Side handle strip
5
Membrane panel
Button A:
- On-off switch. After switching on, the
"FULL" mode is activated
Button B:
- Selection of the color temperature (by
pressing several times you can switch
through the following modes)
FULL –100 klx (4300K)
MIX I –60 klx (3500K)
MIX II - 60 klx (3800K)
MIX III –60 klx (4100K)
MIX IV –60 klx (4400K)
MIX V –60 klx (4700K)
MIX VI –60 klx (5000K)
Button C and button D:
Brightness control in 10 steps:
(+) increase the illuminance level
(-) decrease the illuminance level
LED mode display:
visualizes the current mode setting by
activating the LED:
blue LED - "FULL" mode a
green LED - "MIX" mode c
"FULL" mode
“MIX” mode
Figure 3: Schematic diagram of the ATO ML 1000 K lamp head
5
3
1
2
4
a
c
B
D
A
C

4
3.3 WORKING AREAS OF THE SUPPORT SYSTEMS
3.3.1 MOBILE STAND MODEL
Use of the mobile stand in conjunction with the lamp head allows 360° rotation around the horizontal axis.
The swivel arm of the stand support is mounted vertically and enables a rotation of 60° around the vertical axis via
the swivel joint.
bis zu 35
°+5°

5
Figure 4: Schematic representation of the mobile stand
Only use the stand support on a level and solid surface.
Once the stand support has been positioned, lock both stand rollers using the brakes.

6
3.3.2 CEILING MOUNT MODEL
The arms of the ceiling mount are mounted vertically and allow a rotation of 2 x 360° around the vertical axis via
the swivel joints.
0
Figure 5: Schematic diagram of ceiling attachment
185 mm
1100 mm

7
3.3.3 WALL MOUNT MODEL
Figure 6: Schematic diagram of wall mount
The arms of the wall mount are mounted vertically and allow a rotation of 360° between the arms and 180° on
the wall around the vertical axis via the swivel joints.
Do not attach any additional loads to the lamp head or stand/support.
1100 mm

8
4 SAFETY FUNCTIONS
The ATO ML 600 B │ ATO ML 1000B | ATO ML 1000 K minor surgical lights have built-in safety functions to protect
the user and patient during operation.
4.1 PROTECTION AGAINST OVERHEATING
In the event that the circuit board overheats (T > 75°C), the light will switch to an emergency lighting mode, with
maximum illuminance limited to 40,000 lx. At the same time, the indication lights for the brightness display will
flash. If the temperature rises even further (T > 80°C), the light will turn off completely by means of a built-in
safety switch. The light will automatically turn on again only when the board temperature is below 50°C again.
WARNING: If the circuit board overheats, the heat sink on the top of the light can become very hot. In this case,
only touch the white plastic handles! There is a risk of injury due to burns!
4.2 UNDERVOLTAGE
In the event of a drop in mains voltage, the light will initially attempt to continue operating with reduced voltage.
When the supply voltage drops below 16 volts (normal: 24 volts), the light automatically turns off and the bright-
ness indicator lights start flashing.
As soon as the mains voltage is restored, the light switches itself back on and adopts the last set parameters
(brightness/color temperature).
4.3 POWER OUTAGE
In the event of a complete power failure, the light will go out. As soon as the mains voltage is restored, the light
switches itself back on and adopts the last set parameters (brightness/color temperature).
4.4 ELECTRICAL DEFECT
The light has a function for monitoring the memory electronics. In the event of a defect, arbitrarily incorrect or
potentially dangerous illuminance levels could occur, which is why the light performs a memory self-test at regular
intervals. This does not take any additional time and runs during operation.
If memory errors occur, the light first uses the last valid memory sector and continues to operate properly. If there
is a complete failure of the memory modules, the light switches off for safety reasons and is to be regarded as de-
fective. When the ON/OFF switch is pressed, the brightness indicator lights flash 5x to indicate a complete failure
of the light. The light cannot be operated in this state!
In this case of error, please contact the service department to order a replacement of the control board!

9
5 EQUIPOTENTIAL BONDING CONDUCTOR
An equipotential bonding conductor is an additional conductor (accessory; not included in the scope of delivery)
that establishes a direct connection between the electrical unit and the equipotential bonding busbar of the elec-
trical installation. The mobile light on a mobile stand as well as the wall-mounted lights have a PE connection on
the housing of the mobile stand or on the wall mount, respectively, so that possible potential differences that can
occur as voltage sources are avoided in the patient environment - including in connection with parallel use of
other units. Such voltage sources can cause currents via the body resistance that not only flow over the patient,
but can also affect or even endanger doctors and nursing staff. Active medical devices may malfunction due to
such outflowing currents.
In class 2 rooms used for medical purposes, in addition to the protective measures according to DIN VDE 0100 Part
410, all external conductive parts within the patient environment are connected (electrically to each other and) to
the equipotential bonding busbar. This means that the equipotential bonding conductor must be connected to an
equipotential bonding busbar.
To ensure that the permissible touch voltage of 10 mV is not exceeded (∆u ≤ 10mV), potential equalization (PE) must be
performed. For this purpose, the PE conductor (see Accessories list) of the light must be connected to the PE busbar.
Note: For wall-mounted lights, the protective earth conductor serves only as a functional earth (protection class
II).
For ceiling-mounted lights, an on-site equipotential bonding conductor must be connected to the respective ceil-
ing panels when installed in class 2 rooms used for medical purposes - as also mentioned in the respective installa-
tion instructions.
Figure 9: Equipotential bonding conductors for mobile stands and wall mounts. Art. No. 4510.30000
Figure 8: PE connection socket on mobile stand
Figure 7: PE connection socket on the mobile stand
with the green/yellow equipotential bonding con-
ductor

10
6 REPROCESSING OF STERILE ACCESSORIES
The cleaning and disinfection procedures described here have been developed and validated in accordance with
the recommendations of the medical societies and the associated standards.
In addition to the procedures mentioned here, please also observe your facility's internal hygiene regulations for
cleaning, disinfection and sterilization of medical devices.
If there are any deviating specifications in your work area, please contact our customer advisory service or
your hygiene specialist.
6.1 STERILIZABLE HANDLE (ALSO "STERILE HANDLE")
The ATO ML 600 B | ML 1000B | ML 1000 K lights are equipped with a blue sterilizable handle (sterile handle) as
standard. The removable handle is steam sterilizable up to 134 °C.
The blue sterilizable handle must be sterilized before initial use and before any further use in a sterile envi-
ronment. Otherwise there is a risk of cross-contamination!
The handle must be removed for sterilization:
To remove, press the two release buttons on the side and pull the steriliza-
ble handle downward.
To attach, slide the handle on until the latch on the side release buttons au-
dibly engages.
Side release button
6.2 DISINFECTION
The sterile handle must be cleaned and disinfected after use. A mechanical process (disinfector) should be used
for cleaning/disinfection.
The following mechanical procedure was validated for effective cleaning/disinfection of the sterile handle using
the WD 290 washer-disinfector from Belimed, program 1 (instruments alkaline):
Table 1: Disinfection
Pre-cleaning:
3 min. pre-rinse
Cleaning:
5 min at 48 °C, followed by 2 min cold rinse and rinse with deionized water.
Disinfection:
5 min. at 93 °C
Drying:
15 min. at 95 °C
Cleaner:
Mediclean forte, Dr. Weigert company
Figure 10: "sterile handle" - sterilizable handle
During surgery, the hand grips often become unsterile; keep addi-
tional hand grips on hand for replacement (consists of Art. No.
4500.04-020 & Art. No. 4500.04-028). Only use handles from PHO-
TONIC. Handles from other manufacturers are not authorized!